Predictors of Respiratory Failure Following Extubation in the SICU
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|ClinicalTrials.gov Identifier: NCT01967056|
Recruitment Status : Unknown
Verified October 2013 by Ulrich Schmidt, Massachusetts General Hospital.
Recruitment status was: Recruiting
First Posted : October 22, 2013
Last Update Posted : October 22, 2013
|Condition or disease|
|Muscle Weakness Renal Failure Respiratory Comorbidities|
Both extubation delay and extubation failure are related to adverse outcomes. A spontaneous breathing trial is therefore recommended to predict extubation readiness. However, depending on the disease entity and local culture, a range of 10-20 per cent incidence of extubation failure has been described from tertiary care hospitals. The aim of this trial is to identify additional variables in surgical patients that can be used to support a clinician's decision on whether or not to extubate a patient's trachea.
Te investigators have recently developed and validated the SPORC (Brueckmann, 2013), a score that predicts the risk of extubation failure following surgery based on patients comorbidities and the acuity of the disease leading to surgery, and the investigators hypothesize that the SPORC will also predict extubation failure in the surgical ICU.
In addition, it is likely that ICU acquired morbidity also predicts extubation failure. In fact, the investigators have recently shown that muscle weakness is a predictor of aspiration (Mirzakhani, 2013), and the investigators speculated that muscle weakness may also respiratory failure after extubation.
Finally, it has been suggested that the increased mortality seen in patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) versus end stage renal disease (ESRD) patients requiring CRRT can be attributed to an increased need for mechanical ventilation. (Walcher, 2011). Therefore, the investigators also hypothesize that acute kidney injury increases the vulnerability of patients to postextubation respiratory failure.
|Study Type :||Observational|
|Estimated Enrollment :||750 participants|
|Official Title:||Predictors of Respiratory Failure Following Extubation in Teh Surgical Intensive Care Unit (SICU)|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||October 2014|
- Respiratory Failure [ Time Frame: 30 days ]The investigators defined respiratory failure as a composite endpoint including reintubation within 72 hours, use of non-invasive ventilation for treatment of extubation failure, and tracheostomy during hospitalization (expected time of 30 days post extubation)
- Reintubation within 72 hours [ Time Frame: 72 hours ]The investigators will follow patients and observe whether they require reintubation within 72 h
- Non-invasive ventilation for treatment of extubation failure [ Time Frame: 72 hours ]The investigators will follow patients and observe whether they require non-invasive ventilation for extubation failure
- Tracheostomy [ Time Frame: Patients will be followed for 30 days of hospitalization ]
- SICU length of stay [ Time Frame: 180 days ]
- Hospital length of stay [ Time Frame: 180 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967056
|Contact: Ulrich Schmidt, M.Dfirstname.lastname@example.org|
|Contact: Jessica Hinesemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Ulrich Schmidt, MD 617-643-4408 firstname.lastname@example.org|
|Principal Investigator:||Ulrich Schmidt, MD||The Massachusetts General Hospital|